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Pre-Solicitation Notice – Notice of Intent to award on a Sole Source Basis Title: Notice of Intent to Award a Sole Source for training and migration of data into an existing LORENZ docuBridge license agreement Notice Number: PCA-NIAID-04840 Agency: Department of Health and Human Services, National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Contracting Office: HHS – Office of Mission Acquisition Solutions Product Service Code (PSC): OC code L069 / PCS Code 18 (Technical Representative Training – training aids and devices) NAICS Code: 513210 (Software Publishers) Place of Performance: NIH/NIAID, 5601 Fishers Lane, Room 5G70, Rockville, MD 20852 Set Aside: Not Applicable (Sole Source) Response Date: 05/04/2026 1:00 PM MST Description This is a Notice of Intent to negotiate on a sole source basis for a firm-fixed-price purchase order to LORENZ International LLC, 1515 Market Street, Suite 1200, Philadelphia, PA 19102 NIH/NIAID has a requirement for a one-time service to import data and provide associated training to the Biomedical Advanced Research and Development Authority (BARDA) federal agency team to migrate into the existing NIAID-owned LORENZ docuBridge software and license agreement. Requirement Details: The Biomedical Advanced Research and Development Authority (BARDA) has a bona-fide need to use NIAID's Software-as-a-Service (SaaS) services for NIAID's LORENZ docuBridge system to facilitate and support BARDA's lifecycle management of all BARDA-sponsored regulatory application submissions to the U.S. Food and Drug Administration (FDA). NIAID provides and supports software and information technology (IT) infrastructure resources for Institutes and Centers across the NIH and other Department of Health and Human Services Operating/Staff Divisions. NIAID offers SaaS using NIAID's resources, including application hosting, database, storage, backups, and related services. NIAID's electronic Common Technical Document (eCTD) LORENZ docuBridge system is built using commercial off-the-shelf software provided by LORENZ Life Sciences Group. If this request is not approved, BARDA will not be able to fulfill its responsibility to submit regulatory filings to the FDA. BARDA will need to duplicate the cost and effort of establishing its own eCTD software. The migration period will begin immediately upon submission of the award and must be completed no later than September 29, 2026. Justification for Sole Source: LORENZ is the manufacturer of the docuBridge software and user license, and the only source capable of providing the required services for the following reasons: Proprietary Technology: The docuBridge software is a proprietary program owned and developed exclusively by LORENZ. docuBridge is an eCTD (electronic common technical document) publishing tool that has been specifically approved by HHS for use as the standard format for submission of pharmaceutical applications to regulatory agencies like the U…

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